Method and device for testing venous valves

• US 5,272,909 A
• Filed: 04/25/1991
• Issued: 12/28/1993
• Est. Priority Date: 04/25/1991
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: Baxter International Inc.
• Inventors: Nguyen, Than, Wieting, David W., Nashef, Aws, Lee, Denis, Abolfathi, Amir H.
• Primary Examiner(s): NOLAND, THOMAS
• Application Number:
  US07/691,258
• Time in Patent Office: 978 Days
• Field of Search: 73/168, 73/866.4, 73/865.9, 73/37, 73/4 R, 73/3, 128/668
• US Class Current: 73/37
• CPC Class Codes: A61B 2017/00707 Dummies, phantoms; Devices simulating patient or parts of patient
• CPC Class Codes: A61F 2/2472 Devices for testing

Abstract

A method and device for testing artificial or natural venous valves. The device comprises (a) a fixture for mounting a sample valve on a liquid flow path, (b) a muscle pump component and/or (o) respiratory pump component and/or (d) capacitance reservoir component and/or (e) vertical hydrostatic column component, all of the components being fluidly connected to the flow path to mimic the muscle pump, respiratory pump, capacitance and hydrostatic impedance effects of actual in situ venous circulation in the mammalian body. The invention includes methods of testing venous valves by mimicking known hemodynamic flow conditions within a mammalian body.

Claims

1. A device for testing venous valves, said device comprising:

(a) a holding fixture for holding a venous valve sample in a substantially fixed position;

(b) an inflow conduit fluidly connectable to said venous valve for passing a flow of liquid through said venous valve;

(c) an outflow conduit fluidly connectable to said venous valve to carry liquid which has passed through said venous valve away from said venous valve;

(d) a muscle pump fluidly connected to said inflow conduit and operative to pump a substantially pulsatile flow of liquid through said inflow conduit and through said venous valve;

(e) a respiratory pump fluidly connected to said outflow conduit and operative to exert cyclic variations in pressure on liquid exiting said venous valve through said outflow conduit.

2. The device of claim 1 further comprising:

a fluidic connection between said outflow conduit and said inflow conduit such that liquid flowing through said outflow conduit will recirculate through said inflow conduit.

3. The device of claim 2 wherein said variable capacitance reservoir comprises:

(i) a rigid outer shell defining an inner chamber therewithin;

(ii) an apparatus for varying the volumetric capacity of said inner chamber;

(iii) an inlet port connectable to said outflow conduit to allow liquid from said outflow conduit to pass into said inner chamber; and

(iv) an outlet port for allowing liquid to flow out of said inner chamber.

4. The device of claim 3 wherein said apparatus for varying the volumetric capacity of the inner chamber of said capacitance reservoir comprises:

an inflatable space occupying member sized, configured and positioned in relation to said inner chamber such that;

(a) inflation of the space occupying member will increase the extent to which said space occupying member protrudes into said inner chamber thereby decreasing the available liquid-holding volumetric capacity of the inner chamber and,

(b) deflation of the space occupying member decreases the extent to which said space occupying member protrudes into the inner chamber thereby increasing the available liquid-holding volumetric capacity of said inner chamber.

5. The device of claim 1 further comprising:

(f) a variable capacitance reservoir fluidly connected to said outflow conduit, said variable capacitance reservoir comprising a reservoir of variable volumetric capacity.

6. The device of claim 1 further comprising:

(g) a hydrostatic column fluidly connected to said outflow conduit.

7. The device of claim 6 wherein said hydrostatic column comprises a tubular conduit of variable height to permit variation in the hydrostatic impedance of fluid flowing through the outlet portion of said conduit.

8. The device of claim 1 wherein said holding fixture comprises first and second annular mounting members positioned in opposing juxtaposition to receive thereon and hold the opposite ends of a segment of blood vessel wherein a venous valve is located.

9. The device of claim 1 wherein said muscle pump comprises:

a rigid outer shell;

a hollow inner chamber within said rigid outer shell;

an inlet port connected to a liquid source for passage of liquid into said hollow inner chamber;

an inlet port check valve positioned in operative relation to said inlet port to permit inflow of liquid into said inner chamber through said inlet port but to substantially prevent backflow of liquid out of inner chamber through said inlet port;

an outlet port connected to said inflow conduit for passage of liquid out of said inner chamber and into said inflow conduit;

an outflow check valve positioned in operative relation to said outflow port to permit outflow of liquid from said inner chamber through said outflow port but to substantially prevent inward backflow of liquid into said inner chamber through said outlet port;

a diaphragm member positioned within said inner chamber and movable back and forth between a "first" position and a "second" position such that;

(a) as the diaphragm member moves from said "first" position to said "second" position liquid within the inner chamber will be forced outwardly through said outlet port; and

(b) as the diaphragm member moves from said "second" position to said "first" liquid will be drawn inwardly through said inlet port into said inner chamber; and

a drive apparatus operatively connected to said muscle pump, said drive apparatus being operative to drive said diaphragm member back and forth between said "first" and said "second" positions.

10. The device of claim 9 wherein said inlet check valve comprises a ball-in-cage valve.

11. The device of claim 10 wherein said inlet check valve comprises a ball-in-cage aortic valve.

12. The device of claim 9 wherein said outlet check valve comprises a tricuspid leaflet-type valve.

13. The device of claim 9 wherein said drive apparatus comprises a pneumatic pulse drive unit.

14. The device of claim 1 wherein said respiratory pump comprises:

a rigid outer shell;

a hollow inner chamber within said shell;

an inlet port connectable to said outflow conduit such that liquid may flow from said outlet conduit into said inner chamber;

an outlet port for allowing liquid to flow out of said inner chamber;

a diaphragm member positioned within said inner chamber and capable of undergoing repeated inflation and deflation such that;

(a) inflation of said diaphragm member causes said diaphragm member to protrude into said inner chamber and,

(b) deflation of said diaphragm member causes said diaphragm member into retract from said inner chamber; and

a drive apparatus for alternately inflating and deflating said diaphragm member to thereby exert cyclic variations in pressure on liquid passing through said inner chamber.

15. The device of claim 1 further comprising:

a temperature control device for controlling the temperature of liquid flowing through the device.

16. The device of claim 1 further comprising:

at least one pressure transducer to measure the pressure of liquid flowing through said device.

17. The device of claim 1 further comprising:

a sample chamber having a liquid-holding sample well formed therein, said venous valve holding fixture being located within said liquid-holding sample well such that liquid within said liquid-holding sample well may surround said venous valve sample.

18. The device of claim 1 further comprising:

a viewing window positioned in said device such that a human operator may view the functional movement of the venous valve sample being tested by said device.

19. The device of claim 1 further comprising:

a vertically inclined conduit fluidly connected to said outflow conduit to provide a hydrostatic column against liquid flowing through said outflow conduit.

20. The device of claim 19 wherein said vertically inclined conduit is of adjustable height, to permit adjustment of the amount of hydrostatic impedance created thereby.